Sequencing-Based Analytics Offer Potential For Rapid Sterility And Adventitious Agent Testing

By Gary Sommerville, Ph.D., Principal Scientist, NGS, Technical Services

Traditional safety release testing for cell and gene therapies relies on culture-based methods that take weeks to complete, significantly extending vein-to-vein timelines for patients facing aggressive diseases. Next-generation sequencing (NGS) offers a rapid, modern alternative by consolidating sterility, mycoplasma, and adventitious agent detection into a single assay. Utilizing a probe capture workflow followed by targeted bioinformatic pipelines, this method processes samples in just 44 to 72 hours. Recent evaluations demonstrate robust detection of fungal, bacterial, and viral species—even at low concentrations. Adopting sequencing-based analytics drastically shortens release timelines, minimizes required sample volumes, and reduces batch rejection risks to deliver critical therapies to patients faster.

Explore the data to see how rapid sequencing-based testing transforms release analytics for advanced medicines.